MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-05-29 for HOVERMATT LATERAL PATIENT TRANSFER DEVICE HM34HS MNI HM34HS MINI manufactured by D.t. Davis Enterprises Ltd. T/a Hovertech International.
[17449440]
"the matt's heat seals in the middle of the mattress gave way and the matt ballooned up so big and round that the pt just about tipped off the bed. The pt was saved by a strong nurse who is now limping around. The serial number of the matt is (b)(4). "
Patient Sequence No: 1, Text Type: D, B5
[17748893]
The hm34dc mini hovermatt was returned to hovertech on 05/23/2012. An investigation was performed. When tested it was noted that the 4 of the 6 stringers were no longer connecting the top of the matt to the bottom. The internal structure of the mattress had failed causing uneven and exaggerated inflation of the product. The hovermatt was discolored and the air inlets were tacky. These conditions are normally attributed to over processing of the mattress, i. E. Being laundered at too high a temperature. After talking to (b)(6) at the facility, she stated that the hovermatt is never machine laundered. It is usually wiped clean using percept in between cases. If extremely soiled the mattress is hand washed and hung to dry. The hovermatt was never sent to laundry. Hovertech international quality records were reviewed to assure that this was not a trended defect or the apparent result of a design deficiency. There are no recorded like failures for this model number product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2531468-2012-00001 |
| MDR Report Key | 2595352 |
| Report Source | 06 |
| Date Received | 2012-05-29 |
| Date of Report | 2012-05-29 |
| Date of Event | 2012-04-25 |
| Date Facility Aware | 2012-04-25 |
| Report Date | 2012-05-29 |
| Date Reported to Mfgr | 2012-04-30 |
| Date Mfgr Received | 2012-04-30 |
| Device Manufacturer Date | 2009-06-01 |
| Date Added to Maude | 2012-08-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SUSAN PAVELKO |
| Manufacturer Street | 513 S. CLEWELL ST. |
| Manufacturer City | BETHLEHEM PA 18015 |
| Manufacturer Country | US |
| Manufacturer Postal | 18015 |
| Manufacturer Phone | 8004712776 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOVERMATT LATERAL PATIENT TRANSFER DEVICE |
| Generic Name | DEVICE, PATIENT TRANSFER, POWERED |
| Product Code | FRZ |
| Date Received | 2012-05-29 |
| Returned To Mfg | 2012-05-23 |
| Model Number | HM34HS MNI |
| Catalog Number | HM34HS MINI |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INTERNATIONAL |
| Manufacturer Address | 513 S. CLEWELL ST. BETHLEHEM PA 18015 US 18015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-29 |